Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy and Parathyroidectomy
The goal of this clinical trial is to learn whether a single polynucleotide injection can improve scar quality after thyroid or parathyroid surgery in adults. It will also assess the safety of the injection.
The main questions this study aims to answer are the following:
Does a single polynucleotide injection improve scar quality 24 weeks after surgery? Does it improve scar appearance and symptoms such as pain, itching, hardness, or tightness? Are there any side effects or wound problems related to the injection? Researchers will compare PLINEST One PN-HPT, a solution containing polynucleotides, with sterile saline, which does not contain polynucleotides.
After the surgical incision is closed, participants will receive one injection along the incision line. Participants will be randomly assigned to receive either PLINEST One PN-HPT or saline.
Scar healing and appearance will be checked after surgery. Formal scar assessments will be performed at 4, 12, and 24 weeks. Scar quality will be assessed using patient and researcher scar rating scales, scar measurements, photographs, symptoms, and participant satisfaction.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, single-center, two-arm, parallel-group, randomized, placebo-controlled clinical trial designed to evaluate the effect of a single intraoperative polynucleotide injection on postoperative scar quality after open thyroidectomy, thyroid lobectomy, or parathyroidectomy.
A total of 80 participants will be randomly assigned in a 1:1 ratio to either the polynucleotide group or the placebo group using a computer-generated randomization list. Participants assigned to the intervention group will receive PLINEST One PN-HPT (Polynucleotides Highly Purified Technology). Participants assigned to the control group will receive sterile 0.9% sodium chloride solution.
The study solution will be administered immediately after completion of skin closure and before the final surgical dressing is applied. In both groups, the total injection volume will be calculated according to incision length at 0.5 mL per centimeter. The solution will be distributed evenly along the entire incision line using a 34-gauge needle and will be injected intradermally or into the superficial subdermal plane. The placebo will be administered using the same volume, anatomical plane, needle size, syringe type, and injection pattern as the active treatment.
Study solutions will be prepared in coded syringes by a member of the research team who is not involved in postoperative scar assessment. Participants, postoperative scar assessors, and the researcher performing the statistical analysis will be blinded to treatment allocation. If differences in injection characteristics make treatment allocation apparent to the person administering the injection, that individual will not participate in postoperative assessments or data analysis.
Surgical skin closure and postoperative wound care will be standardized between the two groups to reduce factors that could affect scar formation.
Participants will undergo preoperative assessment and postoperative evaluations on day 1, days 7 to 10, and at weeks 4, 12, and 24. An optional long-term assessment may also be performed at week 52. Standardized digital photographs will be obtained using consistent lighting, camera distance, participant position, and background whenever possible.
Scar quality will be evaluated over time using the Patient and Observer Scar Assessment Scale (POSAS), the Vancouver Scar Scale, clinical scar measurements, standardized photographs, scar-related symptoms, participant satisfaction, wound complications, and local or systemic reactions related to the injection. The primary assessment time point is postoperative week 24. Changes over time and differences between treatment groups will be evaluated using appropriate repeated-measures statistical methods.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kartal
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Istanbul, Kartal, Turkey (Türkiye), 34865
- Kartal Dr Lutfi Kırdar City Hospital
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Contact:
- koray ıslek, md
- Phone Number: +905380457016
- Email: islekkoray@gmail.com
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Principal Investigator:
- Burak Kersin, md
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Sub-Investigator:
- Zeynep Erdoğan Çetin, md
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Sub-Investigator:
- Koray Islek, md
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 40 to 60 years.
- Scheduled to undergo open thyroidectomy, thyroid lobectomy, or parathyroidectomy through a standard anterior cervical (Kocher) incision.
- Undergoing anterior neck surgery for the first time.
- Able to provide written informed consent.
- Willing to attend the planned postoperative follow-up visits.
- Able and willing to comply with the study procedures.
Exclusion Criteria:
- Younger than 40 years or older than 60 years.
- Previous anterior neck surgery.
- Pre-existing scar in the planned incision area.
- History of hypertrophic scar or keloid formation.
- Previous radiotherapy to the neck.
- Active dermatologic disease involving the anterior neck.
- Active local or systemic infection.
- Uncontrolled diabetes mellitus.
- Current use of systemic corticosteroids or immunosuppressive medications.
- Pregnancy or breastfeeding.
- Known hypersensitivity to fish, salmonid-derived products, polynucleotides, or any component of PLINEST One.
- Coagulation disorder or clinically significant bleeding tendency.
- Use of anticoagulant therapy that constitutes a contraindication to intradermal injection.
- Any contraindication to mesotherapy, intradermal injection, or injectable biostimulant procedures.
- Inability or unwillingness to comply with the planned follow-up assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PN-HPT Group
Participants will receive a single intraoperative injection of PLINEST One PN-HPT along the surgical incision immediately after skin closure. Intervention: PLINEST One PN-HPT (CE 0373-Marked Class III Medical Device Containing Highly Purified Polynucleotides) |
PLINEST One is a CE 0373-marked Class III medical device containing PN-HPT (Polynucleotides Highly Purified Technology).
The formulation contains polynucleotides and does not contain hyaluronic acid, mannitol, local anesthetics, corticosteroids, vitamins, peptides, or other added bioactive ingredients.
A single dose will be administered immediately after skin closure and before the final surgical dressing.
The solution will be injected intradermally or into the superficial subdermal plane along the entire surgical incision using a 34-gauge needle.
The total volume will be calculated as 0.5 mL per centimeter of incision length and distributed evenly along the incision line.
Other Names:
|
|
Placebo Comparator: Placebo Group
Participants will receive a single intraoperative injection of sterile 0.9% sodium chloride along the surgical incision immediately after skin closure. Intervention: Sterile 0.9% Sodium Chloride |
Sterile 0.9% sodium chloride solution will be administered as the placebo comparator.
A single dose will be injected immediately after skin closure and before the final surgical dressing.
The solution will be injected intradermally or into the superficial subdermal plane along the entire surgical incision using a 34-gauge needle and a 3 mL Luer-lock syringe.
The total volume will be calculated as 0.5 mL per centimeter of incision length and distributed evenly along the incision line.
The injection volume, anatomical plane, needle size, syringe type, and injection pattern will match those used in the PN-HPT group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient and Observer Scar Assessment Scale (POSAS) Score at 24 Weeks
Time Frame: 24 weeks after surgery
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Postoperative scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS v3).
Total and subscale scores from the patient and observer assessments will be compared between the PN-HPT and placebo groups.
Patient and Observer Scar Assessment Scale 3.0 (POSAS 3.0) with scores ranging from 6 to 60; higher scores indicate worse scar quality.
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24 weeks after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient and Observer Scar Assessment Scale (POSAS) Scores at 4 and 12 Weeks
Time Frame: 4 and 12 weeks after surgery
|
Postoperative scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS v3).
Total and subscale scores will be compared between the PN-HPT and placebo groups.
Patient and Observer Scar Assessment Scale 3.0 (POSAS 3.0) - Observer Scale, with scores ranging from 6 to 60; higher scores indicate worse scar quality.
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4 and 12 weeks after surgery
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Vancouver Scar Scale Score
Time Frame: 4, 12, and 24 weeks after surgery
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Scar quality will be assessed using the Vancouver Scar Scale, including its clinical scar characteristics.
Scar quality will be assessed using the Vancouver Scar Scale (VSS), with total scores ranging from 0 to 13; higher scores indicate worse scar quality.
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4, 12, and 24 weeks after surgery
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Scar Width
Time Frame: postoperative day 1 and 4-12- 24 weeks after surgery
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Scar length will be measured in millimeters at the time of surgery and at 4, 12, and 24 weeks postoperatively.
The change in scar length from the time of surgery will be assessed at each follow-up visit.
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postoperative day 1 and 4-12- 24 weeks after surgery
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Collaborators and Investigators
Publications and helpful links
General Publications
- Araco A, Araco F, Raichi M. Clinical efficacy and safety of polynucleotides highly purified technology (PN-HPT(R)) and cross-linked hyaluronic acid for moderate to severe nasolabial folds: A prospective, randomized, exploratory study. J Cosmet Dermatol. 2023 Jan;22(1):146-155. doi: 10.1111/jocd.15064. Epub 2022 May 26.
- Araco A, Araco F, Raichi M. An Exploratory Study of PN HPT for Treating Postsurgical Atrophic and Depressed Scars. J Cosmet Dermatol. 2025 Jan;24(1):e16764. doi: 10.1111/jocd.16764.
- Kim JH, Jeong JJ, Lee YI, Lee WJ, Lee C, Chung WY, Nam KH, Lee JH. Preventive effect of polynucleotide on post-thyroidectomy scars: A randomized, double-blinded, controlled trial. Lasers Surg Med. 2018 Mar 25. doi: 10.1002/lsm.22812. Online ahead of print.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KDLK-KBB-PNHPT-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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